Doug Zatzick, MD
TSOS Principal Investigator
Professor, Department of Psychiatry and Behavioral Sciences
University of Washington School of Medicine
The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study
Clinical research; TSOS; Trauma Registry; Embedded pragmatic trial; Stepped-wedge design; Cluster-randomized trial; Pragmatic trial; PRECIS-2
- Trauma Survivors Outcomes and Support (TSOS) was designed as a stepped-wedge, cluster-randomized pragmatic trial at 25 trauma centers in the United States, with 935 patients consented so far.
- Researchers’ hypotheses for the intervention group versus the control group included decreased post-traumatic stress disorder (PTSD), lower rates of depression and suicidal ideation, and less alcohol abuse.
- The advantage of a stepped-wedge design is the mitigation of site variability as sites contribute patients to both control and intervention conditions.
- The TSOS trial targets real-world decisions and is generalizable to sites, patients, and providers, but tradeoffs include regulatory intensity and ongoing development of pragmatic follow-up assessments.
Everyone in TSOS begins as a control participant, and TSOS training at trauma centers includes assessing these controls and linking them with primary care if needed.
It is important to do empiric research, such as asking participants “Had you known in advance what study participation would be like, would you still participate?”
Researchers hope that after TSOS ends, some of the electronic screening and consent documents will remain at sites.
In the startup year of TSOS, regulatory issues were key in getting trauma registry data from patients, and researchers hope to have access to this data as the trial progresses.
One challenge of stepped-wedge design is that phased roll-out limits trial flexibility particularly with regard to recruitment pauses.
For information on the TSOS trial, visit The Living Textbook https://bit.ly/2vp1hJX
@Collaboratory1, @DougZatzickMD , #steppedwedge, #depression, #PTSD, #clinicalcare, #pragmatictrial, #ePCT, #pctGR